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Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities
  • Completed the trial BIAsp-1236

Exclusion Criteria:

  • Planned changes in use of any prescription medication that may interfere with glucose regulation
  • Known or suspected allergy to trial products or related products
  • Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
  • Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIAsp

Arm Description

Outcomes

Primary Outcome Measures

Number of Hypoglycaemic episodes
Occurrence of adverse events

Secondary Outcome Measures

HbA1c (glycosylated haemoglobin)
Prandial increment in blood glucose
7-point blood glucose profile

Full Information

First Posted
October 8, 2012
Last Updated
February 22, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01704378
Brief Title
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
Official Title
A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 18, 2001 (Actual)
Primary Completion Date
March 14, 2003 (Actual)
Study Completion Date
March 14, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Description
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal
Primary Outcome Measure Information:
Title
Number of Hypoglycaemic episodes
Title
Occurrence of adverse events
Secondary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin)
Title
Prandial increment in blood glucose
Title
7-point blood glucose profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent obtained before any trial-related activities Completed the trial BIAsp-1236 Exclusion Criteria: Planned changes in use of any prescription medication that may interfere with glucose regulation Known or suspected allergy to trial products or related products Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Kotka
ZIP/Postal Code
48210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Gjøvik
ZIP/Postal Code
NO-2819
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Horten
ZIP/Postal Code
NO-3188
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kirkenær
ZIP/Postal Code
2260
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Notodden
ZIP/Postal Code
NO-3675
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Helsingborg
ZIP/Postal Code
254 43
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Motala
ZIP/Postal Code
591 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Derby
ZIP/Postal Code
DE7 1DY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Scarborough
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

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